Yesterday, 23andMe provided an update on its blog (see “23andMe Provides An Update Regarding FDA’s Review”) about how it will respond to the FDA’s recent warning letter. In a nutshell, the company will continue to sell the same Personal Genome Service (“PGS”) kits, but new customers will only have access to ancestry-related genetic information and tools, and to their raw data. No health-related information will be provided, for now. Existing customers will continue to have access to all tools, including health-related information.
I’ll note that this is exactly what I predicted would happen in my blog post about the FDA warning letter (see “The FDA Orders 23andMe to Stop Marketing Medical Tests”). You heard it here first! It’s really the most logical approach while 23andMe communicates with the FDA.